Improving cancer immunotherapy; Senseonics’ Eversense delayed; FDA acknowledges Alkermes’ Resubmission; 3D breast ultrasound improves diagnosis

Posted on Dec 31, 2020 by Delveinsight

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Improving cancer immunotherapy by recovering a warning system

Cancer cells, most of the time, develop tactics to elude the immune system. A research team that is led by scientists at Memorial Sloan Kettering Cancer Center has recognized one such mechanism, and it believes aiming it with drugs could potentially enhance responses to immuno-oncology treatments.

A protein called ENPP1, which coats cancer cells, impedes warning signals of tumor formation before they can reach immune cells, the researchers elucidated in a study published in the journal Cancer Discovery.

In mouse models of breast and colorectal cancers, the team showed detaching ENPP1 made the tumors more responsive to anti-PD-1 and anti-CTLA-4 immune checkpoint inhibitors. The over-expression of the protein rendered otherwise treatment-sensitive tumors resistant to the immuno-oncology agents.

When cancer cells divide, chromosomes become unstable with abnormal duplications, mutations, or losses. Snippets of DNA from these unstable chromosomes are likely to shift outside of a cell’s nucleus into the cytoplasm. These rogue DNA pieces can be identified by cells and set off an alarm to immune cells that can then begin an attack.

Senseonics’ 180-day Eversense glucose monitor delayed  

Senseonics’ plans to launch its new, long-term diabetes sensor implant will be pushed to the middle of next year as the FDA reviewers continue to be inundated with by-product submissions targeted at the COVID-19 pandemic.

The upcoming version of the Senseonics Eversense continuous glucose monitoring system, a smartphone-connected device, first approved in June 2018, entirely inserted under the skin, intends to double its life span from 90 days to six months.

However, the company has got word from the FDA to anticipate delays of at least two months for its application while the agency asks its staff to do emergency reviews of coronavirus tests and other medical devices.

The problem matches what Senseonics has heard from other medtech developers presently trying to get their products reviewed, the company said, noting that there is still potential for the FDA to get to an approval decision before the end of 2021’s second quarter.

FDA acknowledges Alkermes’ Resubmission of New Drug Application 

Alkermes declared that the U.S. Food and Drug Administration (FDA) had accepted receipt of the company’s New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has allocated the application a new Prescription Drug User Fee Act (PDUFA) target date of June 1, 2021.

The FDA had rejected its schizophrenia and bipolar I because of manufacturing problems at the company’s Wilmington, Ohio, facility.

Alkermes said in a statement that the observations noted in the Complete Response Letter (CRL) were specific to specific development batches of ALKS 3831. The company assumes this issue has been resolved, and sufficient data is available to address these observations.

Alkermes will work closely with the FDA as it finishes its review of the ALKS 3831 NDA and remains devoted to making ALKS 3831 available to patients as soon as possible.

3D breast ultrasound improves diagnostic certainty

A new software-based application assists clinicians visualize breast anatomy volumetrically and provide a comprehensive characterization of lesions.

The application, designed for the Hologic (Bedford, MA, USA) SuperSonic MACH 40 system, enables clinicians to obtain high-resolution B-mode and ShearWave PLUS volumetric elastography data and investigate areas of interest. Breast tissue can be observed in any perspective plane of the 3D volume, including coronal or C-plane. MultiSlice display lets the 3D volumes be seen slice-by-slice, while MultiPlanar display virtually reconstructs the slices in any orientation, using the acquired and stored volume.

The UltraFast image capturing technology of up to 20,000 frames per second ensures smooth images with diminished speckle, enhanced lesion conspicuity, and no resolution loss, regardless of lesion location within the breast, including in patients with dense breast tissue. Moreover, pairing the 3D imaging with ShearWave PLUS elastography, better tumor size estimation, and clear margin definition is available in pre-operative settings and monitors and assesses breast cancer patients during and after neoadjuvant chemotherapy.

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